Clinical studies, also called clinical trials, help determine if investigational drugs, medical devices, and procedures are safe and effective for treating or preventing diseases and other health conditions.
Clinical studies follow a specific set of standards and are closely regulated to help protect study participants. An independent Ethics Committee or Institutional Review Board reviews and monitors each study closely to safeguard the rights and welfare of participants. Nevertheless, all clinical studies and investigational products have risks, including the potential to make participants sick or uncomfortable. Although safety precautions are put in place to protect people who participate in clinical studies, a participant’s condition or health could remain the same, improve, or get worse. Any known risks and side effects of the investigational product and study procedures will be discussed during the informed consent process, but there may be unknown risks.
If you choose to participate in a study, we encourage you to communicate freely with the study doctor and staff throughout the study. If you have questions or concerns about any aspect of the study, you should feel comfortable discussing them with the study doctor at any time.
Taking part in a study is voluntary. If the study doctor determines that you qualify for participation based on a screening process, you may choose to participate or not participate. You will be given time and opportunity to ask questions before deciding what you want to do. Your decision will in no way affect current or future treatment you receive outside the study. If you choose to participate, you will need to follow study instructions and complete study related activities BUT you may withdraw from the study at any time for any reason without penalty or loss of benefits to which you are otherwise entitled.
You can visit any doctor to meet your health needs during a study. You should tell other medical professionals you see that you are participating in a clinical study and always communicate openly with the study doctor regarding other care you receive.